BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM

    MDR report key: 21601221 · Received March 13, 2025

    Report

    Report Number
    3014526664-2025-00045
    Event Type
    Injury
    Date Received
    March 13, 2025
    Date of Event
    February 14, 2025
    Report Date
    March 13, 2025
    Manufacturer
    SILK ROAD MEDICAL
    Product Code
    NTE
    UDI-DI
    00811311021062
    PMA / PMN Number
    K230402
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT ASSOCIATED WITH THIS COMPLAINT WAS NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS. A REVIEW OF THE MANUFACTURING RECORDS FOR THIS DEVICE WAS COMPLETED AND NO ISSUES WERE IDENTIFIED THAT COULD HAVE LED TO THE ADVERSE EVENT REPORTED. AS THE DISSECTION WAS CAUSED BY THE ARTERIAL SHEATH OF THE ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM (NPS) LEADING TO THE THROMBUS FORMATION AT THE ACCESS SITE AND STROKE EVENT, THIS EVENT WILL BE REPORTED FOR THE NPS. COMPLAINTS WILL CONTINUE TO BE REVIEWED AND MONITORED FOR TRENDS. ALL REASONABLY AVAILABLE INFORMATION HAS BEEN PROVIDED BY THE COMPANY AT THE TIME OF SUBMISSION OF THIS REPORT. THE FIELDS THAT ARE BLANK ARE NOT AN OMISSION AND INDICATE THAT THE INFORMATION IS EITHER NOT APPLICABLE OR CURRENTLY UNAVAILABLE. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER A RIGHT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE PATIENT EXPERIENCED WEAKNESS ON THE CONTRALATERAL SIDE. IMAGING REVEALED A DISSECTION FLAP WHICH WAS CAUSED BY THE ARTERIAL SHEATH OF THE ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM AND OCCLUSION AT THE ACCESS SITE. THE DISSECTION WAS REPAIRED SURGICALLY AND THROMBUS WAS ALSO REMOVED. ADDITIONAL INFORMATION STATED INFARCTS WERE SEEN IN IMAGING AND THE EVENT WAS CLASSIFIED AS CEREBROVASCULAR ACCIDENT (CVA). THE PATIENT HAS MADE A COMPLETE RECOVERY POST INTERVENTION. AS THE DISSECTION WAS CAUSED BY THE ARTERIAL SHEATH OF THE ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM (NPS) LEADING TO THE THROMBUS FORMATION AT THE ACCESS SITE AND STROKE EVENT, THIS EVENT WILL BE REPORTED FOR THE NPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1451586 ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE NTE SILK ROAD MEDICAL 306219 00811311021062

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Required Intervention